Reviva Pharmaceutical Holdings, Inc. (RVPH) stock prices were up a monumental 57.75% shortly after the trading day commenced on April 26th, 2021, bringing the price per share up to USD$6.72.
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What is RP5063?
This news came hot on the heels of the announcement of the full details for the results of RVPH’s Phase 2 clinical trial for RP5063 (brilaroxazine), its flagship drug candidate for the treatment of Acute Schizophrenia.
What does RP5063 do?
RP5063 has the potential to modulate and stabilize the D/5-HT system on account of its novel pharmacological profile against critical dopamine and serotonin receptors. The drug has exhibited exceptional capabilities that make it a frontrunner in competing treatments because of its potent affinity and surgical selectivity for the receptors it targets, which are implicated for schizophrenia and other comorbid symptoms.
RP5063 Phase 2 Clinical Trial
The Phase 2 trial aimed to assess the safety and efficacy of the drug in a randomized, double-blind, placebo-controlled, multicenter clinical study. 234 subjects with varying degrees of acute schizophrenic or schizoaffective disorders were given either RP5063 or a placebo, with the drug having met its primary endpoint. A statistically significant reduction by 20 in the total Positive and Negative Syndrome Scale (PANSS) when comparing reports from baseline with those of the placebo indicated massive success.
All safety endpoints were met by RP5063, including clinical, prolactin, fasting glucose, EKG, body weight, labs, and lipids. The drug also improved cognition and the ability to function socially, while reducing both positive and negative symptoms. Should there be a positive outcome on a relevant endpoint in the pivotal third phase of the clinical study, the U.S. Food and Drug Administration has agreed to consider a potential “Superior Safety” label claim for the drug.
Scope of RP5063
With a massive scope of 3.5 million people affected by schizophrenia in the U.S. alone, and with no existing therapies that adequately address the complexities of the disorder, RP5063 has enormous potential. The drug also lacks the host of side effects associated with current antipsychotic treatments, which the company posits could lead to a reduction in discontinuation and non-compliance rates.
Future Outlook for RVPH
The implications of the success of Phase 2 trials are not lost on investors, evidenced by the huge surge in RVPH stock prices. With such an effective treatment for a disorder with as massive an unmet need as that of schizophrenia, RP5063 could dominate the space with its medical footprint. Current and prospective investors are hopeful for this to usher in significant and sustained increases in shareholder value.